The Senior Regulatory Affairs Specialist is responsible for managing and supporting regulatory submissions and ensuring compliance with pharmaceutical regulations throughout the product lifecycle. This role involves preparing dossiers, coordinating with health authorities, and providing regulatory guidance to cross-functional teams.
Key Responsibilities:
Regulatory Submissions & Documentation
- Prepare, review, and submit regulatory dossiers for new product registrations, renewals, variations, and post-approval changes in accordance with local and international regulations.
- Ensure dossiers are complete, accurate, and compliant with regulatory guidelines.
- Manage electronic submissions (eCTD) and regulatory databases.
Compliance Monitoring & Updates
- Monitor changes in regulatory policies and guidelines relevant to the company's products and advise the team accordingly.
- Support audits and inspections by regulatory authorities, ensuring documentation and processes meet compliance standards.
Cross-Functional Collaboration
- Collaborate with R&D, Quality Assurance, Manufacturing, and Marketing teams to incorporate regulatory requirements in product development and commercialization.
- Provide regulatory advice to project teams to facilitate smooth product approval and market access.
Regulatory Intelligence
- Keep abreast of developments in local and international regulatory environments.
- Participate in professional regulatory networks and forums.
Support Regulatory Affairs Team
- Mentor junior regulatory affairs staff as needed.
- Assist in planning and executing regulatory strategies under the guidance of senior management
Qualifications: - Bachelor's degree in Pharmacy, Life Sciences, Chemistry, or related field.
- 4-7 years of experience in pharmaceutical regulatory affairs.
- Knowledge of regulatory requirements and submission processes for pharmaceutical products in key markets (e.g., Vietnam, ASEAN, US, EU).
- Experience with dossier preparation and electronic submissions (eCTD preferred).
- Strong attention to detail and organizational skills.
- Good communication and interpersonal skills.
Key Skills:
- Regulatory submissions & dossier management
- Knowledge of pharmaceutical regulations and guidelines
- Document control and quality compliance
- Cross-functional teamwork
- Problem-solving and analytical skills
- Time management and ability to meet deadlines
Preferred:
- Experience in pharmaceutical product lifecycle management
- Familiarity with GMP, GDP, and other quality standards
- Ability to work independently and as part of a team
- Proficiency in English (written and spoken)